Product code FDF
- Device name
- Colonoscope And Accessories, Flexible/Rigid
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260423 | Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026-05-28 |
| K252457 | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2026-01-30 |
| K244029 | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | Endorobotics Co., Ltd. | 2025-09-24 |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L | Fujifilm Corporation | 2025-05-23 |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | Olympus Medical Systems Corporation | 2025-05-15 |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | Pentax of America, Inc. | 2025-01-03 |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | Actuated Medical, Inc. | 2024-10-04 |
| K232043 | Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-02-16 |
| K231254 | GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. | 2023-11-03 |
| K232922 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | 2023-10-20 |
| K230332 | Ambu® aScope™ Colon; Ambu® aBox™ 2 | Ambu A/S | 2023-09-15 |
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | 2023-09-08 |
| K230588 | Aer-O-Scope Colonoscope System | Gi View , Ltd. | 2023-08-17 |
| K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | 2023-02-10 |
| K213773 | Insufflation Retention Device | Bpendo, LLC | 2022-07-21 |
| K220158 | G-EYE System | Smart Medical Systems , Ltd. | 2022-04-11 |
| K213578 | Balloon Dilatation Catheter | Hangzhou AGS MedTech Co., Ltd. | 2022-04-06 |
| K210052 | Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/w... | Saneso, Inc. | 2022-04-01 |
| K220007 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | 2022-02-10 |
| K211819 | DiLumen C2 and Tool Mount | Lumendi, LLC | 2021-10-22 |
| K210981 | Pure Vu System | Motus GI Medical Technologies , Ltd. | 2021-04-29 |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | 2021-04-21 |
| K202469 | G-EYE System | Smart Medical Systems , Ltd. | 2020-10-26 |
| K192793 | Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I | Olympus Medical Systems Corp. | 2020-07-17 |
| K192588 | G-EYE System | Smart Medical Systems , Ltd. | 2020-04-15 |
| K190669 | Endotics | Era Endoscopy S.R.L. | 2020-01-03 |
| K192664 | FUJIFILM Endoscope Model EC-760Z-V/L | Fujifilm Corporation | 2019-11-20 |
| K191220 | Pure Vu System | Motus GI Medical Technologies , Ltd. | 2019-06-06 |
| K190649 | FUJIFILM Endoscope Model EC-760S-V/L | Fujifilm Corporation | 2019-05-07 |
| K181084 | PENTAX Video Colonoscopes (EC Family) | Pentax of America, Inc. | 2019-01-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06973786293246 | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory) | 2026-06-04 |
| 06973786293222 | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory) | 2026-06-04 |
| 07290016992113 | Aer-O-Scope Disposable Colonoscope | G.I. VIEW LTD | 2026-05-27 |
| 00677964090912 | Defendo Single Use Valve Kit | MEDIVATORS INC. | 2022-02-08 |
| 00677964094682 | Defendo Single Use Valve Kit | MEDIVATORS INC. | 2021-11-22 |
| CS3307 | Endoch | Endoch Inc | 2019-06-01 |
| CS5007 | Endoch | Endoch Inc | 2019-06-01 |
| CS5000 | Endoch | Endoch Inc | 2019-06-01 |
| CS4308 | Endoch | Endoch Inc | 2019-06-01 |
| CS43078 | Endoch | Endoch Inc | 2019-06-01 |
| CS4307 | Endoch | Endoch Inc | 2019-06-01 |
| CS4300 | Endoch | Endoch Inc | 2019-06-01 |
| CS3308 | Endoch | Endoch Inc | 2019-06-01 |
| CS33078 | Endoch | Endoch Inc | 2019-06-01 |
| CS33068 | Endoch | Endoch Inc | 2019-06-01 |
| CS3306 | Endoch | Endoch Inc | 2019-06-01 |
| CS3300 | Endoch | Endoch Inc | 2019-06-01 |
| CS50078 | Endoch | Endoch Inc | 2019-06-01 |
| CS5008 | Endoch | Endoch Inc | 2019-06-01 |
| 08714729339342 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339366 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339373 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339434 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339410 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339403 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339397 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 00677964052453 | DEFENDO Valve and Connector Kit | MEDIVATORS INC. | 2016-09-21 |
| 00677964055911 | DEFENDO Valve and Connector Kit | MEDIVATORS INC. | 2016-09-21 |
| 00677964055928 | DEFENDO Air/Water/Suction and Biopsy Valve | MEDIVATORS INC. | 2016-09-21 |
| 00677964060250 | DEFENDO Air/Water/Suction and Biopsy Valve | MEDIVATORS INC. | 2016-09-21 |